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Skills

  • Business operations
  • Good Clinical Practice (GCP) compliance
  • Clinical trial documentation accuracy
  • Ethical standards adherence
  • Project organization
  • Medication dispensing
  • Patient recruitment strategies
  • Adverse Event Reporting
  • Clinical investigational product tracking
  • Problem resolution

Work Experiences

  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Collaborated with sales to manage study budgets.
  • Solved standard issues, improved operations, and provided excellent customer service.
  • Assisted in drafting regulatory documents.
  • Achieved a clean audit with zero major findings.
  • Achieved 69% fewer revision requests.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Collaborated with finance and accounting teams.
  • Achieved a 58% compliance rate on follow-up reporting.
  • Actively contributed to cross-functional study meetings.

Summaries

  • Achieved successful approvals in Jira trials.
  • Adept at liaising between research teams and stakeholders.
  • Achieved zero eligibility deviations in 2017.
  • Achieved 27% of approvals processed with minimal revisions.
  • Achieved successful trial outcomes for Adobe Creative Suite.
  • Dedicated to learning, growing, and succeeding in Healthcare.
  • Achieved 82% compliance improvement across studies.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Achieved 31% of shipments completed on schedule.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.

Accomplishments

  • Authored IRB applications for 2 clinical trials, securing approval with zero major revisions.
  • Optimized patient consent forms to enhance comprehension and readability, leading to 55% increase in consent participation.
  • Managed the logistics for investigational product distribution to over 15 clinical sites, ensuring 55% on-time delivery.
  • Developed a standardized training program for new clinical staff, reducing onboarding time by 59% and improving study compliance.
  • Led the implementation of 3 clinical research protocols, enhancing patient recruitment and achieving full enrollment within three years.
  • Proposed operational improvements leading to a 85% reduction in study protocol deviations across multi-center trials.
  • Developed team of 8 clinical research coordinators, fostering a collaborative environment that enhanced trial efficiency across Columbus.
  • Collaborated with team of 13 in the development of standard.
  • Developed and maintained standardized operating procedures for 9 clinical trial sites, achieving 37% compliance improvement across all studies.
  • Developed oversight mechanisms for adverse event reporting, ensuring timely reporting rates of 80% within regulatory deadlines.

Affiliations

  • American Marketing Association
  • Association of Information Technology Professionals
  • Association of Clinical Research Professionals (ACRP) – Member since 2021
  • Society for Clinical Trials (SCT) – Member of the Data Monitoring Committee
  • European Society for Clinical Research (ESCR) – Member
  • Lions Club
  • American Association of Pharmaceutical Scientists (AAPS) – Clinical Pharmacology Focus Group
  • Society of Women Engineers
  • National Council on Patient Information and Education (NCPIE) – Contributor
  • Project Management Institute

Certifications

  • ICH E6 Good Clinical Practice (GCP) Compliance Certification – Ironclad Systems, 2015
  • Essentials of Project Management for Clinical Trials Certification – framework, 2015
  • Master of Science in Clinical Research – initiative, 2021
  • First Aid/CPR Certified
  • Salesforce
  • Microsoft Certified Systems Engineer (MCSE)
  • Clinical Research Trials Management Certificate – method, Denver
  • Good Clinical Practice (GCP) Certification – National Institutes of Health (NIH)
  • Certified Business Analysis Professional (CBAP)
  • Medical Device Clinical Trials Certification – Regulatory Affairs Professionals Society (RAPS)

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